Clinical Data Specialist

Luminate Medical • Chicago, IL

1d

About The Position

At Luminate Medical, the mission is to make cancer care more human. The company is developing revolutionary wearable devices to address common side effects of cancer treatment, such as hair loss and peripheral neuropathy. Their latest solution, Lotus, aims to make at-home cancer care more accessible and efficient. The Clinical Data Specialist will own and drive clinical data activities across clinical trials, from EDC build to data cleaning and database readiness. This role is an opportunity to be part of an award-winning team and contribute to life-changing devices in a fast-paced environment, with a focus on patient impact.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Data Science, or related field
• 3–7+ years with a Bachelor’s Degree, or 0-3+ years of experience with a Master’s Degree
• Experience or coursework related to clinical trial data capture
• Hands-on experience with EDC systems (e.g., Clincapture Captivate, Medidata Rave, etc.)
• Experience building EDCs (CRFs, edit checks, database structure)
• Experience performing UAT
• Understanding of data cleaning, query management, and database lock processes
• Experience working directly with clinical research sites to resolve queries
• Ability to clearly communicate data issues and drive resolution across stakeholders

Nice To Haves

• Experience in medical device clinical trials (especially NSR or pivotal studies)
• Experience in startup, small teams, and/or fast-paced environments
• Experience supporting regulatory submissions (e.g., FDA)
• Experience supporting data analysis and collaborating with biostatisticians
• Experience working on blinded studies or complex trial designs
• Exposure to oncology trials and working with oncology research sites

Responsibilities

• Manage clinical data activities across one or more clinical trials
• Generate and manage data queries with the EDC and work directly with clinical sites to resolve queries in a timely manner
• Develop and pull study reports (e.g., data listings, query reports, data completeness metrics)
• Ensure data integrity and quality through ongoing data reviews, cleaning, and reconciliation activities
• Support database lock activities and ensure audit readiness
• Build, configure, and maintain EDC systems (including CRF design, edit checks, and data structure, medical coding)
• Lead User Acceptance Testing (UAT), including test script development and execution
• Contribute to development of data management plans, data review guidelines, and SOPs
• Identify opportunities to improve data workflows and implement scalable processes in a startup environment

Benefits

• Highly competitive salary comparable with multinational medical device companies
• Flexible benefits package
• Health insurance
• Pension
• Company laptop
• Headphones
• Camera
• Flexible working hours
• Generous vacation policy

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level